Status:
UNKNOWN
A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets
Lead Sponsor:
Vince & Associates Clinical Research, Inc.
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.
Detailed Description
Study consists of a screening visit, four treatment periods and a final follow-up visit. Each treatment period consists of a four night in-house stay followed by two outpatient visits. Each treatment ...
Eligibility Criteria
Inclusion
- Able to understand, sign and date the informed consent form
- Male or female 18 to 55 years old with a diagnosis of epilepsy who are stable
- Body mass 18 to 34 kg/m, inclusive
- Is continuously receiving a fixed dose of their AED medication(s)for a minimum of 30 days prior to screening
- Stay on the same dosages of their routine concomitant medications throughout the study
- Healthy, as determined by pre-study medical history, vital signs, physical exam, ECG and the opinion of the investigator
- Normal renal function per laboratory test
- No clinically relevant labs.
- Negative for hepatitis B, C and HIV
- For females, negative pregnancy test
- Negative for drugs of abuse and alcohol
- Nonsmoker or has not smoked within the past six months.
- Some over-the-counter medications may be permitted at the discretion of the investigator
- Able to communicate well and comply with study procedures, requirements and restrictions
Exclusion
- History or presence of clinically significant medical disorders
- Have a current psychiatric disorder
- History of status epilepticus within 90 days of screening
- Any other condition that the investigator would feel could interfere with the safety of the subject or the study protocol.
- Taking three or more AED medications
- Use of felbamate, aspirin, carbapenem antibiotics, rifampin, ritonavir, macrolide antibiotics, cholestyramine, and/or risperidone.
- Use of any investigational agent or medical device within 30 days of screening.
- History of clinically significant drug allergy that in the opinion of the investigator may compromise the subject's safety or study results.
- History of known hypersensitivity to divalproex sodium or its excipients
- History of alcohol or drug abuse or dependence in the past 5 years
- Consumed alcohol, caffeine or other xanthine-containing foods or beverages within 48 hours prior to each clinic admission.
- Consumed grapefruit and/or grapefruit containing products within days prior to admission to the clinic on Day -1 and they agree not to consume grapefruit and/or grapefruit containing products for the duration of their study involvement
- Participated in any strenuous physical exercise within 72 hours before admission to the clinic on Day 1 and agrees to abstain from the duration of their study involvement.
- Acute illness at screening and/or at admission to the clinic
- Lactose intolerance or unusual dietary habits.
- Blood donation within 8 weeks of admission to this study
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01898676
Start Date
July 1 2013
End Date
December 1 2013
Last Update
July 12 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, United States, 66212